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NCT06286228Not yet recruiting

Registry of Haploidentical Hematopoietic Stem Cell Transplantation in Adult With Hematologic Disease

Source: ClinicalTrials.gov · Last updated 1 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The goal of this observational study is to register hematologic patients with haploidentical hematopoietic stem cell transplantation (haploHSCT). The main questions it aims to answer are: * 1-year progression free survival rate * 1-year overall survival rate * Graft-versus-host free relapsed free survival at 30-day, 100-day, 180-day and 1-year * Chronic Graft-versus-host free relapsed free survival at 180-day and 1-year * Rate of Neutrophil and platelet engraftment * Efficacy of donor specific antibody desensitization * Relapsed rate * Primary and late graft failure * Safety and complication of haploHSCT * Complication of viral, bacterial, and fungal infection * Viral reactivation * Comparison outcomes between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT * Comparison cost-effectiveness of treatment between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT Participants will be collected the data of baseline diagnosis, treatment, treatment results of all admission and follow-up visits from hospital medical record.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
43 (estimated)
First submitted
22 Feb 2024
Start date
1 Apr 2024
Primary completion date
1 Apr 2029
Lead sponsor
Siriraj Hospital
NCT number
NCT06286228

What you commit to

  • Study type: Observational
  • Planned participants: 43
  • From 1 Apr 2024 to the primary completion date, 1 Apr 2029
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • HIV infection, active hepatitis B, active hepatitis C
  • active infection
  • history of other malignancy except basal cell carcinoma and carcinoma of the cervix in situ

Other

  • A pregnant woman and/or refusal of contraception

Who the study is looking for

  • Patients diagnosed with hematologic diseases indicated for treatment with haploidentical hematopoietic stem cell transplantation including
    • Myeloid diseases (acute myeloblastic leukemia, myelodysplastic syndrome, chronic myelocytic leukemia, classical and non-classical myeloproliferative disorders)
    • Lymphoid disease (acute lymphoblastic leukemia, lymphoma)
    • severe aplastic anemia
  • Unable to find a matched sibling donor (MSD) or matched unrelated donor (MUD), and no alternative treatments
  • Eastern Cooperative Oncology Group (ECOG) 0-2
  • normal AST and ALT, creatinine \<2g/dL, and left ventricular ejection fraction ≥50%
  • age \>18 years
  • Capable of informed consent and provision of written informed consent before any study procedures
  • Capable of attending all study visits according to the study schedule
  • Female subjects who is childbearing potential must have a negative result for pregnancy test

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.